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Nov. 18 — The FDA said it won’t be regulating laboratory-developed tests anytime soon, a decision
that elicited praise from the lab industry and Republican lawmakers Nov. 18.

The FDA will wait until the next presidential administration to move forward with
its plan to oversee such tests, the agency said in a statement. The agency was expected
to issue final policies on the lab developed tests, known as LDTs, by the end of this
year.

Lab test makers, such as Laboratory Corporation of America and Quest Diagnostics,
stand to benefit from the delay. The Food and Drug Administration released two draft
guidance documents in 2014 that explained how the agency planned to oversee laboratory
developed tests, or those made by lab companies, in the same way as it regulates diagnostic
kits manufactured by medical device companies. The LDTs are currently under the authority
of another federal agency.

“We have been working to develop a new oversight policy for laboratory developed tests,
one that balances patient protection with continued access and innovation, and realize
just how important it is that we continue to work with stakeholders, our new Administration,
and Congress to get our approach right,” FDA press officer Tara Goodin said in a statement
provided to Bloomberg BNA Nov. 18.

“We plan to outline our view of an appropriate risk-based approach in the near future,”
the agency’s statement added.

The draft guidance documents described the FDA’s plans to take over oversight of LDTs
from the Centers for Medicare & Medicaid Services, which was granted the authority
to oversee the tests in the Clinical Laboratory Improvement Amendments.

Device companies, which make the in vitro diagnostic (IVD) kits, largely supported
the FDA’s planned oversight of LDTs. They argue the CLIA standards for lab tests aren’t
as stringent as the ones they must follow for IVDs and thus put device makers at a
disadvantage.

Lab Industry Responds

The American Clinical Laboratory Association (ACLA), a lab industry group, heralded
the announcement as a sign the FDA won’t issue the final LDT guidance documents.
In a Nov. 18 statement, the ACLA said it “applauded today’s announcement by the Food
and Drug Administration (FDA)
that it will not release a final guidance to regulate laboratory developed tests and
instead work with Congress and other stakeholders to determine the best solution to
reform.”

In addition, the FDA’s move is a victory for innovation and patients, the ACLA’s president,
Alan Mertz, said. The group has opposed the FDA’s plans to change how lab tests are
regulated and, in 2014, hired prominent attorneys Paul Clement, a former solicitor
general, and Laurence Tribe, a Harvard University law professor, to represent it on
matters related to the draft guidance documents.

Waiting until President-elect Donald Trump and the next Congress take power paves
the way for a transparent discussion on how LDTs should be regulated, Mertz said.

Another opponent of the FDA’s plans, Rep. Michael Burgess (R-Texas), also praised
the delay and said it’s a victory for precision medicine, according to a Nov. 18
statement. Burgess is the chair of the House Energy and Commerce Subcommittee on Commerce,
Manufacturing and Trade. Full Energy and Commerce Committee Chairman Fred Upton (R-Mich.)
also praised the FDA’s move.

AdvaMedDx, a trade association for IVD makers, declined to comment on the FDA’s announcement.
The device industry group had strongly supported the FDA’s LDT oversight plans.

Cautious Move

Delaying a decision on the LDT documents reflects a cautious attitude toward making
any big changes in policy during the change in administrations, attorney William Garvin
told Bloomberg BNA Nov. 18. Garvin is a Washington-based life sciences attorney at
Buchanan Ingersoll and Rooney PC.

Given the fact that people are uncertain about what the new administration is going
to do with regards to certain FDA regulatory positions and priorities, the FDA is
trying its best to hold off on taking positions that would need to get revised once
Trump is in office, Garvin said.

Fate of Draft Guidance Documents

The FDA didn’t provide a clear answer about its plans for the draft guidance documents.
Goodin, in a separate e-mail to Bloomberg BNA, repeated the agency’s statement that
it will wait until Trump and a new Congress are in power before making any changes
to LDT oversight.

“I think FDA will wait until they understand what the new administration will look
like before they take any actions on the guidances,” Garvin said. In the interim,
manufacturers are likely to take a variety of approaches when dealing with these guidance
documents. Some will want to follow the draft documents and others will ignore them,
he told Bloomberg BNA.

It’s fairly common for manufacturers to follow guidance documents that are in draft
form.

To contact the reporter on this story: Michael D. Williamson in Washington at
mwilliamson@bna.com

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